Index [assets.cambridge.org]assets.cambridge.org/97805218/54962/index/9780521854962_index.pdf · Index AAP (American Academy of Pediatrics), 48, 57 Abbott Laboratories Fund, 277 abortion

Index

AAP (American Academy of Pediatrics),48, 57

Abbott Laboratories Fund, 277abortion policies

stem cell research and, 20Abrams, Thomas, 129, 130absorption, distribution, metabolism and

elimination studies. See ADMEAcademy of Managed Care Pharmacy.

See AMCPacetysalicylic acid, 151. See also aspirinAcquired Immune Deficiency Syndrome.

See HIV/AIDSAct-Up New York, 306ADAP (AIDS Drug Assistance

Program), 310, 311Additional Safeguards for Children in

Research, 57, 58, 59“adequate provision,” 157ADME studies (absorption, distribution,

metabolism and elimination), 48, 56genetics and, 83

Administrative Procedure Act. SeeAPA

adverse event reporting system. SeeAERS

advertising, 3DTCA, 127reminder, 156–157

AERS (adverse event reporting system),55

FDA and, 54Africa

AZT in, 273–274HIV/AIDS in, 28, 273, 339, 347–348

Africa, sub-SaharanHIV/AIDS in, 273, 452IP rights in, 346

African Americansantidepressants and, 80clinical testing and, 93health literacy for, 88high blood pressure among, 84pain medications for, 80race-based drug therapies for,

94smoking and, 86Tuskegee syphilis study and, 19,

101Africans

alternative treatments for, 90AIDS activism (medical), 15, 301–308

Act-Up New York, 306ATAC, 307, 316collaboration in, 308–311community involvement for, 308conflicts of interest and, 316–318ETAG, 307in EU, 307FDA approval and, 308, 312–314FPC and, 311NIH and, 308pharmaceutical industry funding for,

318Project Inform, 306

AIDS Drug Assistance Program. SeeADAP

AIDS Treatment Activists Coalition. SeeATAC

Altbach, Philip, 267

471

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472 Index

alternative treatment(s)for Africans, 90for Asians, 90for minorities, 90

Alzheimer’s Disease, 20AMA (American Medical Association),

77, 133AMCP (Academy of Managed Care

Pharmacy), 238American Academy of Pediatrics. See

AAPAmerican College of Physicians, 145

medication recommendations by, 145American Society for Reproductive

Medicine, 116Annan, Kofi, 349anthrax

Cipro and, 268in US, 267

antibioticsrisk-benefit ratios for, 137

antidepressants, 13, 77African Americans and, 80Ashkenazi Jews and, 85for children, 54flouxetine, 76GSK research for, 77Hispanic Americans and, 80, 84paroxetine, 76SSRI v., 219, 287suicidal ideation from, 77venlafaxine, 77

antiretroviralsin Gillespie-White/Attaran study, 344in Kenya, 347in Norway, 347pricing patterns for, East Africa,

346–347in Tanzania, 347

antiviral drugs. See drugs, antiviralAP (Associated Press)

Tuskegee syphilis study and, 101APA (Administrative Procedure Act)

drug regulations and, 116ART (assisted reproductive technology)

Fertility Clinic Success Rate andCertification Act and, 115

processes for, 116stem cell research and, 115

AsiaHIV/AIDS in, 28

Asians, 84alternative treatments for, 90belief systems for, 89

aspirin, 150–152Bayer and, 151development of, 151medicinal properties, 151

assisted reproductive technology. SeeART

ATAC (AIDS Treatment ActivistsCoalition), 307, 316

Attaran, Amir, 343Australia

cost guidelines in (new drugs), 237stem cell research in, 120

Austriastem cell research in, 119

Axios Foundation, 277AZT

in Africa, 273–274HIV/AIDS and, 270, 302, 304NIH and, 270side effects of, 303

Bale, Harvey, 265Baltimore Lead Abatement Study,

72Bardes, Charles, 131Barshefsky, Charlene, 340Bayer, 151–152

aspirin and, 151Farbe, IG, and, 151Prontosil development at, 27

belief system(s)for Asians, 89for Hispanic Americans, 89informed consent and, 103

Best Pharmaceutical for Children Act.See BPCA

Best Pharmaceuticals for Children Act of2002, 18

beta blockers, 143Tenormin, 143Toprol XL, 143

Bidilnitric oxide deficiency and, 95race-based drug therapies and, 95

Bill and Melinda Gates Foundation, 11,358, 367, 391

endowment for, 33HIV/AIDS research and, 35






Index 473

multiple perspectives system and, 277tropical disease research and, 33

biochemistrypharmacology and, 149–150

Biologics Control Act, 49biotech industries. See industries, biotech“black box” labels

FDA and, 13“blockbuster” drugs, 29, 328–329Boston Globe, 219Botswana

HIV/AIDS in, 277, 279BPCA (Best Pharmaceutical for Children

Act), 50, 51, 69, 77IOM and, 69on pharmacovigilance, 54

Brave New World (Huxley), 115Brazil

IP rights in, 268Brenner v. Manson, 337“brief summary”

in reminder advertisements, 156Broder, David, 375bupropion, 86Burroughs, Valentine, 17, 19, 103, 376, 394Bush, George W, 112, 117, 119“business stealing”

drug sales and, 173

Campbell, William C, 11Canada

drug price controls in, 327stem cell research in, 120

cancer. See therapies, cancerCarter, Jimmy, 389CDC (Centers for Disease Control), 391Central Hudson Gas & Electric Corp. v.

Public Service Commission of NewYork, 188, 189

CFR (Code of Federal Regulations)Additional Safeguards for Children in

Research in, 57, 58on pediatric research, 57, 59

chemotherapy, 26dyestuffs and, 26

Childhood Immunization Initiative, 256children. See also pediatrics; research,

pediatricantidepressants for, 54clinical research and, 17–18informed consent for, 43–44

SSRI and, 396Thalidomide and, 17vaccines for, 231–232, 355, 446

Chinainformed consent in, 44IP rights in, 267stem cell research in, 120

Chloramphenicol, 49CIOMS (Council for the International

Organizations of Medical Sciences),17, 37

International Ethical Guidelines forBiomedical Research InvolvingHuman Subjects, 37, 41, 42

“minimal risks” guidelines, 71, 73on pediatric research, 57, 68

Ciproanthrax and, 268Bayer and, 268

ClarinexClaritin v., 142

Claritin, 141, 142Clarinex v., 142

Clean Air Act (US), 114Clemente, CL, 264clinical equipoise, 62–63, 74Clinical Investigation of Medicinal

Products in the Pediatric Population,58, 59

clinical research. See research, clinicalclinical studies. See trials, clinicalclinical trials. See trials, clinicalClinton, Bill, 340, 347cloning, 114–116

in France, legal limits, 119Human Cloning Prohibition Act, 113reproductive, 111SCNT, 110, 111in South Korea, legal limits, 120US government restrictions on, 118

Code of Federal Regulations. See CFRCollaborating Centers for Influenza,

353Commercial Speech Doctrine, 188, 438

WLF and, 189–190common indications. See diseases,

commoncomparator products, 46“compassionate use” programs

for HIV/AIDS research, 25Competitive Media Reporting, 177






474 Index

Consumer-Directed BroadcastAdvertisements, 157

DTCA and, 157Contract With America, 114controlled substances

DEA and, 146general medications and, 146

costs, drugcontrols for, 133–134for regulation, 15

costs, research, 27–28development costs for, 27

Council for the InternationalOrganizations of Medical Sciences.See CIOMS

Crooks, Glenna, 19“cultural competency,” 88cultural practices

belief systems as part of, 89individualized therapies and, 89–91

Daniels, Norman, 135Danzis, Scott, 132data monitoring committee. See DMCDCT (direct-to-consumer) Promotion,

165DEA (Drug Enforcement Agency), 146Declaration of Helsinki. See Helsinki

Declaration of Ethical Principles forMedical Research Involving HumanSubjects

“Declaration on Universal Norms onBioethics,” 41

Delaney, Martin, 104, 253, 397detailing. See physician detailingDetmer, Donald, 130diabetes mellitus, 84Dickey Amendment (US)

HHS and, 117stem cell research and, 111, 121

didanosinein clinical trials, 304FDA approval for, 305for HIV/AIDS, 303

diets. See nutrition“direct benefit”

EU Directive on Clinical Trials and, 73in pediatric research, 73–74

direct-to-consumer promotions. SeeDTC (direct-to-consumer)promotions

Dirksen, Everett, 240diseases, common

clinical research for, 28diseases, rare

clinical research for, 29occurrence rates for, definition, 30“Orphan Drug Law” and, 30

diseases, tropical, 28Bill and Melinda Gates Foundation

and, 33foundations for, 31–33The Global Fund to fight AIDS,

Tuberculosis and Malaria and, 32suggested funding for, by nation, 31WHO and, 31

diseasification, 149DMC (data monitoring committee), 62Doctors’ Trial, 38“Dodge Ball Vioxx,” 14Doha Declaration on TRIPS and Public

Health, 258, 338, 342, 350, 459Dolder-Club-Meetings, 32Domagk, Gerhard, 27Donohue, Julie, 129dosing, drugs

under ethical templates, 221–222in individualized therapies, 94“off-label” use for, 69, 132pediatric calculations for, 48in pediatric research, 52–53

double-blind trials, 24scientific ethics and, 23

Drews, Jurgen, 10, 11drug dosing. See dosing, drugsDrug Enforcement Agency. See DEAdrug labeling. See labeling, drugsdrug licensing. See licensing, drugsdrug pricing. See pricing, drugsdrug recalls. See recalls, drugdrug research. See research, clinicaldrug safety. See safety, drugsdrug sales. See sales, drugdrugs, antiviral

for influenza, 354drugs, “blockbuster,” 29, 328–329drugs, fixed-dose combination

clinical trials for, 38as treatment option, 38

drugs, “lifestyle,” 127, 253. See also drugs,prescription

MUSE, 163






Index 475

drugs, new, 186, 235in Australia, cost guidelines for, 237“blockbuster,” 29, 328–329clinical trials for, 38cost-effectiveness of, 231–236development costs for, 27, 252, 311–312government reimbursement for (in

US), 288–289for HIV/AIDS, 253misbranding, 185–186older v., 142–143in UK, cost guidelines for, 238in UK, launches for, 25in US, 25

drugs, prescription, 136–145disadvantages of, 143DTCA and, sales from, 173FDA and, 155fixed-dose combination of, 38for hypertension, 139“lifestyle,” 127marketing for, 153–154, 170MUSE, 163OxyContin, 162–163“Patient Package Inserts” for, 155pharmaceutical industry and, 3Prograf, 164risk-benefit ratios for, 137sales figures for (2003), 153, 174Viagra, 213, 217–219

DTC (direct-to-consumer) promotions,165

DTCA (direct-to-consumer-advertising),127, 131, 154, 169, 170–172, 366. Seealso advertising

“adequate provision” as part of, 157Competitive Media Reporting and, 177consumer involvement in, 171–172Consumer-Directed Broadcast

Advertisements and, 157educational value of, 178–179in EU, 202expenditures for, 17, 127Fairness Doctrine and, 182FDA and, 128, 129, 170financing arrangements for,

adjustments, 182–183general medication use and, influence

on, 144, 175–176government policy alternatives to,

180–183

for “lifestyle” drugs, 127literature on, 179long-term influence of, 172–173, 181National Ambulatory Medical Care

Survey and, 177objectives of, 128, 153–154, 170patient information and, 202patient treatment and, influence on,

169, 176–177, 182patient-physician relations and,

influence on, 170physician detailing and, 128physicians’ visits and, influence on, 175prescription drug sales and, 173print advertisements for, 156public health care and, 128–131,

169–170, 179reminder ads and, 156–157Rogaine and, 171surveys for, 153, 172, 173–175, 177television and, 156treatment therapies and, influence on,

170, 177–178types of, 156

Dunn, Belynda, 206Dworkin, Ronald, 279

The Economist, 235“Effects of a Single Dose of

Dextroamphetamine in AttentionDeficit Hyperactivity Disorder: AFunctional Magnetic ResonanceStudy,” 61

EG (embryonic germ) cells, 121. See alsostem cells

Eisenberg, Rebecca S, 269Eli Lilly & Company, 77, 255, 334

Elizabeth Arden and, 334Elizabeth Arden, 334embryonic germ cells. See EGembryonic stem cells. See ESEMEA (European Medicines Agency)

PC and, 70Energy Security Act (US), 114Enola beans

patents for, 266Proctor, Larry, and, 266

ES (embryonic stem) cells, 110, 121. Seealso research, stem cell; stem cells

ETAG (European Treatment ActivistGroup), 307






476 Index

“Ethical Considerations in HIVPreventive Vaccine Research,” 40

ethical templates, 216–222cost advantage constraints within,

214–215cost-worthiness as part of, 214coverage decision hierarchy within,

211–212deliberations under, 216drug dosage under, 221–222effectiveness of treatment as part of,

214elements of, 210generic rationales for, 212–215for pharmacy benefit management,

209–222SSRI under, 219–221Viagra under, 217–219

ethics, 21–26. See also ethical templates;ethics, corporate; ethics,Hippocratic; ethics, medical; ethics,scientific

business, 396in clinical research, 9, 38–41governments and, 109Hippocratic, 36in pediatric research, 56–62review committees, 45

“Ethics and Clinical Research,” 413ethics, corporate

medical ethics v., 29pharmacy benefit management and,

209–222ethics, Hippocratic, 36. See also

ethics, medical; HippocraticOath

ethics, medical, 21–24, 26in clinical research, 36corporate ethics v., 29drug therapy under, 22Hippocratic Oath as part of, 22

ethics, scientific, 21–26in clinical research, 36data disclosure as part of, 23double-blind trials and, 23experimental reproducibility and, 23“non-scientific” v., 23

ethnicity. See also minoritiescross-racial variability and, 83definitions for, 82

EU (European Union)drug price controls in, 327DTCA in, 202FP6 in, 119stem cell research policy within, 118

EU Directive on Clinical Trials, 37, 70“direct benefit” and, 73funding sponsor obligations for, 45patient selection and, 70pediatric research and, 68

European Treatment Activist Group. SeeETAG

“expanded access” programsfor HIV/AIDS research, 25

Fair Access to Clinical Trials Act, 78Fair Pricing Coalition. See FPCFairness Doctrine, 182False Claims Act. See FCAFarbe, IG, 151Fauci, Anthony, 354FCA (False Claims Act), 132, 185, 193

“double falsehood” requirements for,192

Frankin v. Parke-Davis and, 191–193,194

“off-label” usage under, 191“qui tam” suits under, 191

FDA (Food and Drug Administration),69, 93, 117, 393

AERS and, 54AIDS activism and, 308, 312–314“black box” warning labels from, 13clinical testing and, 92Consumer-Directed Broadcast

Advertisements and, 157didanosine and, approval of, 305drug promotion violations and,

162–164DTCA and, 128, 129, 170FDCA and, 159, 184generic v. brand name medications

and, 140genomic research and, 295labeling regulations by, 49, 438manipulation of, 314–315Modernization Act of 1997 for, 18MUSE and, 163Office of Pediatric Therapeutics and,

69






Index 477

“off-label” usage approval by, 187, 193OTCs and, specifications, 141–142pediatric research and, 48PREA and, 69prescription drugs and, 155race-based drug therapies and, 95risk management and, 285statutory limitations for, 51vaccines and, 256Viagra and, approval for, 217Vioxx and, 16WLF and, 189, 190

FDAMA (Food and DrugAdministration Modernization Act),50, 190, 439

FDCA (Food, Drug and Cosmetic Act),12, 49, 98, 393

FDA and, 159, 184Kefauver-Harris Amendments to, 49labeling under, 186–187misbranding under, 161, 184“off-label” promotions under, 185, 187promotional development under, 166,

167promotional regulation under, 159usage directions under, for labels, 186

Federal Register, 117Female Health Company, 277Fen-Phen, 13Fertility Clinic Success Rate and

Certification Act, 115FET (frozen embryo transfer), 428First Amendment (US Constitution)

Commercial Speech Doctrine as partof, 188, 438

drug promotions under, 184“off-label” promotion under, 188–191,

193WLF and, 190–191

fixed-dose combination drugsclinical trials for, 38as treatment option, 38

flouxetine, 76Fluss, Sev S, 17, 57Foege, Bill, 358, 367Food and Drug Administration. See FDAFood and Drug Administration

Modernization Act. See FDAMAFood, Drug and Cosmetic Act of 1934.

See FDCA

Foreign Assistance Act (US), 114formularies

insurance and, 147third party payer systems and, 147

Forum for Collaborative HIV Research,298

foundationsBill and Melinda Gates Foundation,

11FP6 (sixth research framework program),

119in EU, 119

FPC (Fair Pricing Coalition), 311France

cloning limits in, 119innovation output in, 333–334stem cell research in, 119

Francis, Tommy, 386Franklin, Ben, 378Franklin v. Parke-Davis

FCA and, 191–193, 194“off-label” promotion and, 191

Frazier, Kenneth, 14frozen embryo transfer. See FETfunding source(s)

for AIDS activism, 318for clinical trials, 45–46, 322–324EU Directive on Clinical Trials and,

45foundations as, 322GCP guidelines for, 45governments, 322ICH and, 45for multiple perspectives systems,

277pharmaceutical industry as, 323responsibilities of, 46for tropical diseases, by nation, 31WHO and, 45

Gallup polls, 4gamete intrafallopian transfer. See GIFTGarber, Alan, 246Gathii, James, 259, 379GCP (Guidelines for Good Clinical

Practice for Trials on PharmaceuticalProducts)

funding sponsor obligations for, 45patient selection and, 70WHO and, 37, 40, 43






478 Index

geneticsADME and, 83Human Genome Project and, 83within individualized therapies, 83–85pharmacodynamic properties and, 83pharmacogenetics, 83research, 91–92variations within, 82

genomic research. See research, genomicGenomic Research in the African

Diaspora Biobank. See GRADGermany

innovation output in, 333stem cell research in, 119

GIFT (gamete intrafallopian transfer),428

Gillespie-White, Lee, 343, 459–460Gillespie-White/Attaran study, 343–344,

348, 459antiretroviral access in, 344compulsory drug licensing in, 460–461patents in, 345poverty thesis in, 345–347treatment costs, annually, 344

Gilmartin, Raymond, 13Gingrich, Newt, 15Global AIDS Fund, 349, 391globalization

disease pandemics as result of, 370health care systems during, 291–292

The Global Fund to fight AIDS,Tuberculosis and Malaria, 341

Johnson & Johnson and, 33Merck Industries and, 33participants in, 33tropical disease research and, 32US contributions to, 341

Goldkind, Sara, 18Good Clinical Practice: Consolidated

Guidance, 59Goodman, Kenneth, 270Gore, Al, 340Gorman, Michael, 259, 380, 382, 383Gorrie, Tom, 367government(s)

drugs development reimbursement by,288–289

DTCA policy and, 180–183ethics and, 109as funding source, 322

in genomic research, 295–296individualized therapies and, policy

development, 93–94moral issues and, 109–110pediatric research policy, 49stem cell research policy and, 109

Grace, WR, 266GRAD (Genomic Research in the

African Diaspora) Biobank, 91Grassley, Charles, 16GSK (GlaxoSmithKline), 274, 389

antidepressant research by, 77Guidelines for Good Clinical Practice for

Trials on Pharmaceutical Products.See GCP

Guillain Barre syndrome, 468

HaitiHIV/AIDS in, 278–279

Hale, G. Victoria, 11Hardin, Garrett, 267, 269Harris polls, 3Hay, Joel, 133, 134Hayes, Arthur Hull, 155health care systems. See also health care

systems, private; health care systems,public

access to, 227chronic care as part of, 376consumer involvement in, 171–172cost-benefit analysis for, 228, 230–231cost-effectiveness for, 228as delivery government role in, 283demand management for, 201–202DTCA and, 128–131, 169–170, 179elderly care as part of, 376expenditures for (US), 134, 225during globalization, 291–292government role in, 283information technologies for, 172, 294limit setting within, 206–207literature for (US), 232–234in The Netherlands, 200nontoxic treatments as part of, 294outpatient care within, 294–295patient’s rights under, 171per capita spending, pharmaceuticals

(international), 226pharmacy benefit management in,

206–207






Index 479

prevention efforts of, 295public pension expenditures (by GDP),

241safety nets for, 376–377third party payer system and, 133–135

health care systems, privateQALY and, 229

health care systems, publicinsurance under, 292–294Medicaid as part of, 292multi-stakeholder cooperation for,

367–368PAPs and, 292, 293Partnership for Prescription Assistance

as part of, 292private enterprise and, 363–365, 466State Children’s Health Insurance

Programs under, 292health literacy, 376

for African Americans, 88consumer surveys and, 178“cultural competency” and, 88language as factor in, 87for minorities, 87–89patient informational practices and, 88

health maintenance organizations. SeeHMOs

Health Sector Assembly. See HSAHeller, Michael A, 269Helsinki Declaration of Ethical

Principles for Medical ResearchInvolving Human Subjects, 17, 37,39, 40, 41, 42, 46, 64, 102, 409

informed consent under, 197“Notes of Clarification” as part of, 39patient selection under, 70placebo controls and, 74

HFE (Human Fertilization andEmbryology) Act (UK), 119

HHS (Health and Human Services), 61,93

Dickey Amendment and, 117rulemaking for, 117

high blood pressureamong African Americans, 84

Hippocratic Oath, 22, 107, 131Hispanic Americans, 82

antidepressants and, 80, 84belief systems for, 89pain medications for, 80

HIV/AIDS (Human ImmunodeficiencyVirus/Acquired Immune DeficiencySyndrome), 1, 371

activism and, 15, 301–306ADAP and, 310in Africa, 28, 273, 339, 347–348in Asia, 28AZT and, 270, 302, 304Bill and Melinda Gates Foundation

and, 35in Botswana, 277clinical research participation and, for

patients, 19clinical testing for, 93combination therapies for, 305, 348,

462“compassionate use” programs for, 25corporate collaborations and, 33–36didanosine for, 303, 304disease markers for, 304drug pricing for, 302“expanded access” programs for, 25Forum for Collaborative HIV

Research, 298in Haiti, 278–279as international pandemic, 281, 452IP rights and, 268mother-to-child transmission, 222, 461new drug development for, 253patents system and, 253patient’s rights and, 104–105possible treatments for, 302poverty and, 338–339property rights and, 379–381protease inhibitors and, 305Rescue Principle for, 381–385in South Africa, 339in sub-Saharan Africa, 273, 452in Tanzania, 277–278, 279Triomune, 349US government funding for, 341–342vaccine development for, 274women and, 372

HMOs (health maintenanceorganizations), 219

HMS Salisbury (ship), 97Holt, Rush, 20Horwitz, Jerome, 270HSA (Health Sector Assembly), 375, 376

members of, 375






480 Index

Hsieh, Nien-he, 364Human Cloning Prohibition Act (US),

113Human Embryonic Stem Cell Registry,

121Human Fertilization and Embryology

Act. See HFEHuman Genome Project, 83, 91Human Immunodeficiency Virus. See

HIV/AIDShuman rights. See rights, humanHume, David, 261Huxley, Aldous, 115hypertension

drug classes for, 139

IAVI (International AIDS VaccineInitiative), 357

ICH (International Conference onHarmonisation of TechnicalRequirements for Registration ofPharmaceuticals for Human Use),37, 40

Clinical Investigation of MedicinalProducts in the Pediatric Populationin, 58, 59

clinical trials and, 45funding sponsor obligations for, 45Good Clinical Practice: Consolidated

Guidance in, 59“minimal risks” guidelines, 73on pediatric research, 57, 68on placebo controls, 74

Idanpaan-Heikkila, Juhana E, 17,57

Idris, Kamil, 265IEC (institutional ethics committee),

62IIPI (Intellectual Property Institute),

342–343, 459on drug access, 343

Imitrex, 211pharmacy benefit management and,

211–212restrictions on, 214

immunization program(s), 386–387National Immunization Days, 390in US, 386–387

imports, drughealth concerns as result of, 293–294under MMA, 239–240

for pharmaceutical industries, 3US Congress and, 328

in vitro fertilization. See IVFIndia

IP rights in, 265–266, 268industries, biotech, 332–333industries, pharmaceutical

AIDS activism and, funding for,318

biotech industries and, 332–333cost containment within, 236–239drug importation for, 3drug manufacturing for, 3drug pricing for, 3as funding source, 323“grand bargain” for, 1–2“innovation deficit” within, 30institutional partners for, 5IP within, 3literature about, 365Medicaid and, 3NGOs and, 5patents within, 10patient’s rights and, 3prescriptions drugs and, 3public image for, 3–4, 394–397sales representatives in, 148–149“silo mentality” in, 236

infertilityIVF and, 116

influenzaantiviral drugs for, 354Asian bird, 291“swine,” 468vaccines for, 256–257, 352–354WHO and, 291

influenza vaccines. See vaccines, influenzainformation, medical sources

for general medications, 147–148Internet, 198sales representatives as, 148in UK, medical, 198–199

information, patient, 199–200. See alsoinformed consent

direct-to-consumer, 202–203DTCA and, 202economic impacts of, 200–201“Informed Patient” Project and,

130, 196, 198, 204–205NHS Direct (UK) and, 202from physicians, 148






Index 481

informed consent, 44–45, 197–199age for, 103for children, 43–44in China, 44in clinical trials, 39cultural belief systems and, 103under Helsinki Declaration of Ethical

Principles for Medical ResearchInvolving Human Subjects, 197

husband-wife relationships and, 44in International Ethical Guidelines for

Biomedical Research InvolvingHuman Subjects, 44

in non-therapeutic clinical research,42–43

The Nuremberg Code of 1947 and, 44under state-controlled systems, 197in UK, 197

“Informed Patient” Project, 130, 196, 198,204–205

innovations. See also drugs, new; patentsin France, 333–334in Germany, 333incentives for, 243–244, 288“off-label” uses and, 290under Orphan Drug Act, 289recognition for, 287–290in UK, 333in US, 333

Institute for OneWorld Health, 11, 381,400, 401

Institute of Medicine, 16institutional ethics committee. See IECInstitutional Review Boards. See IRBsinsurance

formularies and, 147intellectual property. See IPIntellectual Property Institute. See IIPIInternational AIDS Vaccine Initiative.

See IAVIInternational Committee of Medical

Journal Editors, 78International Conference on

Harmonisation of TechnicalRequirements for Registration ofPharmaceuticals for Human Use. SeeICH

International Ethical Guidelines forBiomedical Research InvolvingHuman Subjects, 37, 41, 42

informed consent as part of, 44

International Society forPharmacoeconomics and OutcomesResearch, 237

Internetdrug sales and, 293medical information and, 198

InvermectinMerck Industries and, 12

Investing in Health, 345IOM (Institute of Medicine), 69, 355, 356,

421“minimal risks” and,

recommendations, 71IP (intellectual property)

alliance models for, 275–280in Brazil, 268challenges to, 260, 265–268corporate investments and, 265development of, 260HIV/AIDS and, 268human rights and, 261–280in India, 265–266, 268industries, pharmaceutical, and, 3Jefferson, Thomas, and, 262Locke, John, and, 262, 263moral imagination and, 275–276multiple perspectives system for,

276–277overprotection of, 269for Pfizer Pharmaceuticals, 268privatization of, 269The Rescue Principle and, 385rights-based defenses of, 262–263in sub-Saharan Africa, 346in “third world” countries, 257–259,

265time limited claims for, 262, 272in US, 267–268, 340utilitarian defenses of, 264–265WIPO and, 265WTO rules for, 346

IRBs (Institutional Review Boards), 58,93, 398

for pediatric research, 60for placebo-controlled clinical trials, 63

Irelandstem cell research in, 119

Israelstem cell research in, 120

Italystem cell research in, 119






482 Index

IVF (in vitro fertilization), 115, 428American Society for Reproductive

Medicine and, 116FET, 428GIFT, 428infertility and, 116Society for Assisted Reproductive

Technology and, 116stem cell research and, 115“test tube babies” from, 115TET, 428in US, 116US government restrictions on, 118ZIFT, 428

Japanstem cell research in, 120

Jefferson, Thomas, 261, 280IP rights and, 262on patent protection, 261

Jews, Ashkenaziantidepressants and, 85

Johnson & JohnsonThe Global Fund to fight AIDS,

Tuberculosis and Malaria and, 33Joint United Nations Programme on

HIV/AIDS. See UNAIDSJournal of the American Medical

Association, 16

Kefauver-Harris Amendments, 14, 334drug safety under, 12FDCA and, 49

Kelly, Pat, 4Kenya

antiretrovirals in, 347Kessler, David, 15Kipling, Rudyard, 295Kordel v. United States, 186

drug labeling and, 187Koski, Greg, 368, 381Kremer, Michael, 244

labeling, drugs“black box,” 13under FDCA, 186–187intended uses and, 438interaction warnings for, 91in Kordel v. United States, 187pediatric rules for, 50regulations for, 49, 438

Laetrile, 15The Lancet, 16language

clinical trials and, as barrier, 19health literacy and, 87informed consent and, as factor for,

103LDC (least-developed countries),

273. See also “third world” nationsdrug distribution in, 279

least-developed countries. See LDCLee, S, 82Leeper, Mary Ann, 277licensing, drugs

clinical research and, 22compulsory, 338, 460–461in South Africa, 339

life expectancy ratesinternational increase in, 236

“lifestyle” drug(s), 127, 253. See alsodrugs, prescription

MUSE, 163Viagra as, 217–218

Lind, James, 97, 108Litchtenberg, Frank, 235Locke, John, 260, 261

on IP rights, 262, 263Luce, Bryan, 222

Macroeconomics and Public Health(WHO), 342

Magnetic Resonance Imaging. SeeMRI

Maimonidesmedical oaths and, 107

major depressive disorder. See MDDmalaria. See also diseases, tropical

drug development for, 388–389institutional partnerships’ research for,

11Malarone and, 388research for, 10, 11

Malarone, 388managed care, 219manufacturing, drugs

for pharmaceutical industries, 3“March of Dimes,” 386marketing. See DTCAMaxwell, John, 395McClellan, Mark, 254McKinnell, Hank, 254






Index 483

MDD (major depressive disorder), 76MHRA and, 76

Mectizan Donation Program, 372, 388,389

WHO and, 372Medicaid. See also health care systems,

publicbenefit allocations under, 209minorities and, 82, 87per capita spending (c. 1970), 225pharmaceutical industries and, 3reimbursement under, 440

medical intervention outcomes‘pharmacoeconomic league tables’

and, 230QALY and, 228

medical technologies, 233informational, 294

The Medical Letter on Drugs andTherapeutics, 147

Medicarebenefit allocations under, 209co-payment requirements for, 289drug benefit for, 133minorities and, 82, 87MMA, 239–240“off-label” usage and, 132per capita spending (c. 1970), 225reform, 328

medications, alternative, 144–145. Seealso alternative treatment(s)

medications, brand name. See also drugs,prescription

generic v., 140–141medications, general. See also drugs,

prescriptionAmerican College of Physicians

recommendations for, 145controlled substances and, 146DTCA and, influence on, 175–176DTCA for, 144ethnicity and, 80, 85FDA and, 140free, 148generic v. brand name, 140–141information sources for, 147–148Nexium, 142OTC, 134, 141, 142patient requests for, 144prescription v. OTC, 141–142side effects of, 146–147

medications, generic. See also drugs,prescription

brand name v., 140–141Medicines and Healthcare Products

Regulatory Agency. See MHRAMedicines and Related Substances Act

(South Africa), 339, 379Medicins Sans Frontieres (Doctors

Without Borders), 259, 349MEDWATCH, 54Merck, George W, 12, 368, 452Merck Industries, 11, 13, 358, 388, 391

The Global Fund to fight AIDS,Tuberculosis and Malaria and, 33

Invermectin and, 12Mectizan Donation Program, 372mission for, 452stock prices for, 16Vioxx and, 13–14

Mesenchymal Stem cells. See MSCMHRA (Medicines and Healthcare

Products Regulatory Agency)MDD and, 76

“minimal risks”CIOMS guidelines for, 71, 73for drug therapies, 22ICH guidelines for, 73IOM recommendations for, 71National Commission definition for,

71, 73for pediatric research, 59–62, 71,

72–73for placebo-controlled clinical trials,

65variability of, 71

minorities. See also African Americans;Asians; Hispanic Americans; Jews,Ashkenazi

alternative medicine and, 90cancer therapies and, 80clinical testing and, 92–93drug access for, non-traditional, 89–90drug toxicity and, 81health literacy for, 87–89individualized therapies and, 81–83Medicaid and, 82, 87Medicare, 82, 87

misbrandingunder FDCA, 161, 184labeling and, 187new drugs and, 185–186






484 Index

MMA (Medicare Modernization Act)(US), 239–240

drug importation under, 239–240managed care expansion under, 240

Modernization Act of 1997, 18moral imagination, 275–276morbidity rates

for vaccine-preventible diseases, 356mortality rates

from Vioxx, 16Motrin, 141MRI (Magnetic Resonance Imaging), 61MSC (Mesenchymal Stem cells), 427multiple perspectives system (IP rights),

276–277Bill and Melinda Gates Foundation

and, 277Merck and, 277NGO funding for, 277WHO and, 279

Murphy, Dianne, 18, 396MUSE (Urethral Suppository)

FDA and, 163usage risks for, 163

National Ambulatory Medical CareSurvey, 177

National Childhood Vaccine Injury Act,449

National Cholesterol EducationProgram. See NCEP

National Commission, 74“minimal risks” definition for, 71, 73

National Immunization Days, 390National Institutes of Health. See NIHNational Medical Association, 19NCEP (National Cholesterol Education

Program), 138Neemix, 266, 270Nelson, Robert, 18Nelson, Skip, 396The Netherlands

health care costs in, 200Neurontin, 132, 133, 191

“off-label” usage for, 192, 431Nevirapine, 461New Zealand

clinical trials in, 102IRBs in, 102

The New York Times, 3, 291Nexium, 142

NGOs (non-governmental organizations)Axios Foundation, 277multiple perspectives system funding

by, 277pharmaceutical industries and, 5

NHRPAC (National Human ResearchProtection Advisory Committee)

pediatric research and, 60NHS Direct (UK), 202NIH (National Institutes of Health), 92

AIDS activism and, 308AZT and, 270Human Embryonic Stem Cell Registry

and, 121research budget for (2004), 234rulemaking for, 117

Nixon, Richard, 114NOAH (Nurturing Orphans of Aids for

Humanity) Ark project, 391Noah, Barbara, 87, 92, 93Noble, Gary, 257non-governmental organizations. See

NGOsNorway

antiretrovirals in, 347The Nuremberg Code of 1947, 101

clinical trials and, 38Doctors’ Trial and, 38informed consent and, 44ten principles for, 38–39

Nurturing Orphans of Aids forHumanity. See NOAH

nutritionindividualized therapies and, 86

oaths, medical, 107–108. See also ethics;Hippocratic Oath

Hippocratic, 22, 107, 131Maimonides and, 107

Office of Pediatric Therapeutics, 69Office of Technology Assessment. See

OTA“off-label” uses (prescription drugs)

dosing for, 69, 132under FCA, 191FDA approval for, 187, 193under FDCA, 185, 187under First Amendment, 188–191, 193in Franklin v. Parke-Davis, 191future applications for, 193–195innovations and, 290






Index 485

Medicare and, 132for Neurontin, 192, 431Parke-Davis and, 132promotion for, 184, 187–188, 438

old age dependency ratios, 242onchoceriasis. See River BlindnessOrphan Drug Act, 30, 289OTA (Office of Technology Assessment),

114, 123OTCs (over-the-counter medications).

See also medications, generalaspirin, 150–152Claritin, 141drug modifications and, 142FDA specifications for, 141–142Motrin, 141Prilosec, 141third party payer system and, 134, 141Zantac, 141

Ottesen, Eric, 389outpatient care, 294–295over-the-counter medicines. See OTCsOxfam, 259OxyContin, 162–163

indicated use violations for, 163usage risks for, 163

PAC (Pediatric Advisory Committee),69

PAPs (Patient Assistance Programs)in public health care systems, 292, 293

Parke-DavisFranklin v. Parke-Davis and, 191–193Neurontin and, 132, 133, 191“off-label” drug uses and, 132

Parkinson’s Disease, 15paroxetine, 76“The Participation of Underrepresented

Minorities in Clinical Research”(Noah), 87

Partnership for Prescription Assistance,292

patent law(s), 337–339Brenner v. Manson, 337development of, 262drug pricing and, 140

patents, 242, 331, 337–338for DNA sequences, 269for Enola beans, 266generic drugs v., 243in Gillespie-White/Attaran study, 345

HIV/AIDS and, 253for Jefferson, Thomas, 261legal protections for, 140, 262, 337–339market competition and, 242within pharmaceutical industries, 10protection for (US), 227, 350in public domain, 244–246reward systems for, 245social benefits from, 448–449in “third world” nations, 258WHO and, 244

Patient Assistance Programs. See PAPs“Patient Package Inserts,” 155patient selection

EU Directive on Clinical Trials and, 70GCP and, 70under Helsinki Declaration of Ethical

Principles for Medical ResearchInvolving Human Subjects, 70

for pediatric research, 70–71patient’s rights. See rights, patient’sPaxil, 54, 65

adverse reactions to, 55efficacy trials for, 55

PC (Pediatric Committee), 70EMEA and, 70

Pearson v. Shalala, 190Pediatric Advisory Committee. See PACPediatric Committee. See PCpediatric research. See research, pediatricPediatric Research Equity Act. See

PREAPediatric Rule, 50pediatrics. See also research, pediatric

AAP and, 48labeling rules, 50“off-label” medication use in, 69

Penicillin, 27Pfizer Pharmaceuticals, 358

IP rights for, 268pharmaceutical industries. See industries,

pharmaceuticalPharmaceutical Manufacturers

Association of America, 133pharmaceutical research. See research,

clinicalPharmaceutical Research and

Manufacturers of America. SeePhRMA

pharmaciesindustrialization of, 26






486 Index

‘pharmacoeconomic league tables,’ 230,232

pharmacogenetics, 83. See alsogenetics

pharmacogenomics, 83pharmacology

biochemistry and, 149–150etymology of, 136

pharmacovigilanceBPCA on, 54in pediatric research, 54–56

pharmacy benefit managementaccountability under, 208decision revision under, 208drug allocation as part of, 208–209ethical template for, 209–222Imitrex and, 211–212Medicaid and, 209Medicare and, 209in public health care, 206–207

Philippines, thestem cell research in, 120

PhRMA (Pharmaceutical Research andManufacturers of America), 77, 311,340, 366

physician detailing, 128, 131, 154,181–182. See also sales, drug

“academic,” 181aids for, 154expenditures for, 131

physician package insert. See PIphysicians

clinical research and, role in,26–27

detailing for, 128DTCA and, influence on, 175mistrust of, 139“patient-centered” practices for,

171sales representatives and, 148

Physician’s Desk Reference, 50PI (physician package insert), 157placebo-controlled clinical trials. See

trials, clinical (placebo-controlled)polio vaccine. See vaccine, poliopolls

Gallup, 4Harris, 3

Polybius (Roman historian), 386Portugal

stem cell research in, 119

poverty, 342–344in Gillespie-White/Attaran study,

345–347HIV/AIDS and, 338–339

PREA (Pediatric Research Equity Act),50, 69

FDA and, 69PAC and, 69requirements for, 51

price controls, 333in Canada, 327in EU, 327in UK, 327

pricing, drugsconflicts over, 311–316“freezes” for, 310for HIV/AIDS, 302market-based, 331patent law (US) and, 140for pharmaceutical industries, 3

Prilosec, 141priority principle, 442Proctor, Larry, 266

Enola beans and, 266profit maximization

in clinical research, 9–12free market systems and, 10

Prograf, 164Project Inform, 306promotions, drug (prescription). See also

sales, drugfor accelerated approval products,

164–165DTC, 165FDA violations for, 162–164FDCA guidelines for, 159, 166,

167under First Amendment, 184introductory campaigns, 165“off-label” use and, 184, 187–188, 438regulation of, 159–162, 167samples as part of, 158statutory framework for, 185–188types of, 158–159, 164–165US expenditures for (2003), 157–158

Prontosil, 27property rights. See rights, propertyprotease inhibitors

HIV/AIDS and, 305public domain

patents in, 244–246






Index 487

publicationsof clinical trials, 46–47

QALY (quality adjusted life years), 228,229

application limitations of, 231cost-effective analysis and, 229, 230costs per year (US), 229private health care and, 229

quality adjusted life years. See QALY“qui tam” suits, 191

race-based drug therapies, 94–96for African Americans, 94BiDil and, 95FDA and, 95

Rand, Ayn, 263Rand Health Care Appropriateness

Methodology Research Program,232, 240

randomized clinical trials. See trials,clinical (randomized)

rare indications. See diseases, rareRatzan, Scott, 130R&D (research and development), 228.

See also drugs, newapproval times for, 296–298for aspirin, 151for AZT, 270, 302, 304for didanosine, 303, 304disease markers in, 297EU pharmaceutical industry

expenditures, 235for HIV/AIDS, 253for Prontosil, 27of protease inhibitors, 305technological risks during, 330US pharmaceutical industry

expenditures (2003), 234recalls, drug, 25

in UK, 25in US, 25–26

regulations, drugAPA and, 116costs for, 15for efficacy, 15for pediatric research, 49–52for promotional materials, 161–162for safety, 15in US, 116–118

Reinhardt, Uwe, 208

Related Agencies Appropriations ActSCNT under, 112stem cell research and, 112, 427

reminder advertisements, 156–157. Seealso DTCA

“brief summary” as part of, 156reproductive cloning, 111

SCNT v., 111, 115The Rescue Principle

HIV/AIDS and, 381–385IP rights and, 385

research and development. See R&Dresearch, clinical (non-therapeutic)

ethical guidelines for, 41–44guidelines for, 414–415informed consent as part of, 42–43Phase I studies for, 42for vulnerable groups, 43–44

research, clinical (therapeutic), 36children and, 17–18for common diseases, 28costs for, 27–28drug licensing and, 22economic pressures for, 26ethical guidelines for, 9, 26–31, 38–41for malaria, 10medical ethics in, 36participation in, 19–20patient’s rights in, 9, 16–20physician’s role in, 26–27profit maximization in, 9–12for rare diseases, 29scientific ethics in, 36stem cell, 9Tuskegee syphilis study, 17

research, geneticDNA arrays as part of, 91for drug therapies, 91–92GRAD and, 91

research, genomic, 295–296FDA and, 295government role in, 295–296

research participation (clinical)for HIV/AIDS, 19language/cultural barriers to, 19for minorities, 19, 20Tuskegee syphilis study and, 19

research, pediatricAAP and, 48ADME studies and, 48adult studies’ extrapolations in, 56






488 Index

research, pediatric (cont.)adverse effects during, undefined, 53CFR on, 57, 59CIOMS on, 57, 68clinical trials for, 48, 51developmental behavior during, 53–54,

56, 290“direct benefit” in, 73–74dosing calculations in, 48ethical guidelines for, 56–62EU Directive on Clinical Trials and,

68as exploitation, 78FDA and, 48government policy for, 49ICH on, 57, 68ineffective dosing in, 52–53ineffective therapies during, 52IRBs for, 60legislative approaches to, 69–70for MDD, 76minimal risks for, 59–62, 71, 72–73NHRPAC and, 60for paroxetine, 76patient condition for, 72–73patient selection for, 70–71Pediatric Rule for, 50pharmacovigilance in, 54–56placebo-controlled clinical trials for,

63–65, 74–75post-approval studies as part of, 56public results of, 51queries for, 58randomized clinical trials for, 62–65regulations for, 49–52“sentinel canaries,” 49as social contract, 75–78variability in, 56

research, stem cell, 20, 110–114abortion policies and, 20Alzheimer’s Disease and, 20ART and, 115in Australia, 120in Austria, 119in Canada, 120in China, 120Dickey Amendment (US) and, 111,

121foreign regulations for, 118–121in France, 119in Germany, 119HFE Act (UK) for, 119

Human Cloning Prohibition Act and,113

in Ireland, 119in Israel, 120in Italy, 119IVF and, 115in Japan, 120for pharmaceutical industries, 9in The Philippines, 120in Portugal, 119private organizations and, 121Related Agencies Appropriations Act

and, 112SCNT as part of, 110in Spain, 119in Sweden, 119in UK, 119–120US government policies for, 109, 118,

122US law and, 111–114

rights, human, 261IP as part of, 261–280

rights, patient’s, 104–107in clinical research, 9, 16–20HIV/AIDS research and, 104–105pharmaceutical industries and, 3under public health care, 171researcher trust and, 101, 104trial participation as part of, 97–100,

105–106rights, property

HIV/AIDS and, 379–381risk management, 285–287

in clinical trials, 285FDA approval and, 285

risk-benefit ratiosfor drug therapies, 22for prescription drugs (antibiotic), 137for prescription drugs (general), 137

River Blindness, 11–12, 388, 469cause of, 469symptoms of, 11

RogaineDTCA and, 171Upjohn and, 171

Rosenthal, Meredith, 129Rotary International, 389–390rulemaking, 117. See also regulations,

drugfor HHS, 117“informal,” 117for NIH, 117






Index 489

Sabin, James, 135SACHRP (Secretary’s Advisory

Committee for Human ResearchProtection), 60

Sachs, Jeffrey, 349safety, drugs, 12–16

antidepressants and, 13Fen-Phen and, 13Kefauver-Harris Amendments and,

12regulations for, 15thalidomide and, 13

sales, drug“business stealing” as part of, 173DTCA and, influence on, 173international share (for US), 227Internet and, 293“sales calls” for, 154

sales representatives. See also physiciandetailing

free medications and, 148honoraria for, 148patient information from, 148in pharmaceutical industries,

148–149physician information from, 148teaching materials and, 148

Salk, Jonas, 372Scanlon, TM, 382Science, 267SCNT (Somatic Cell Nuclear Transfer),

110, 111genetic information from, 111grafting as part of, 111under Related Agencies

Appropriations Act, 112reproductive cloning v., 111,

115Second Treatise on Government (Locke),

260Secretary’s Advisory Committee for

Human Research Protection. SeeSACHRP

Section 301 watch list, 339–340South Africa and, 339trade sanctions under, 339

selective serotonin reuptake inhibitors.See SSRI

“A Sensible Compromise on Viagra,”219

“sentinel canaries,” 49Shirkey, H, 49

side effectsof AZT, 303in clinical trials, 468of general medications, 146–147

“silo mentality,” 236Singleton, Peter, 130sixth research framework program. See

FP6small pox, 355, 387Smith, Adam, 261smoking

African Americans and, 86bupropion and, 86individualized therapies and, 86–87

Society for Assisted ReproductiveTechnology, 116

Somatic Cell Nuclear Transfer. See SCNTSouth Africa

compulsory drug licensing in, 339HIV/AIDS in, 339Medicines and Related Substances

Act, 339, 379on Section 301 watch list, 339

South Koreacloning limits in, 120

Spainstem cell research in, 119

SSRI (selective serotonin reuptakeinhibitors), 219–221

antidepressants v., 219, 287children and, 396data-suppression for, 398

State Children’s Health InsurancePrograms, 292

stem cell research. See research, stem cellstem cells, 110. See also research, stem

celladult, 111EG, 121ES, 110, 121MSC, 427

steroidsplacebo-controlled clinical trials for,

74–75Strategic Defense Initiative (US),

114subspecialty care, 146suicidal ideation

antidepressants and, 77Sulfanilamide, 49Superfund (US), 114“superior good,” 443






490 Index

surveys, consumersfor DTCA, 153, 172, 173–175, 177health literacy and, 178

Swedenstem cell research in, 119

TanzaniaAbbott Laboratories Fund in,

277antiretrovirals in, 347HIV/AIDS in, 277–278, 279

Taurel, Sidney, 255Teagarden, Russell, 135Tenormin, 143“test tube babies,” 115testing, clinical

African Americans and, 93FDA and, 92for HIV/AIDS, 93minorities and, 92–93NIH and, 92

TET (tubal embryo transfer), 428Thalidomide, 13, 49, 393

children and, 17therapeutic cloning. See SCNTtherapies, cancer

minorities and, 80therapies, combination

for HIV/AIDS, 305, 348, 462Triomune, 349

therapies, druggenetic research for, 91–92medical ethics and, 21–22race-based, 94–96risk-benefit ratios for, 22

therapies, individualized, 81–92. See alsotherapies, drug

cultural practices and, 89–91drug dosage in, 94environmental factors in, 86–87genetic factors within, 83–85government policy for, 93–94minorities and, 81–83non-genetic factors in, 85–91nutrition and, 86polymorphism and, 83smoking-related activities and, 86–87

There’s No Such Thing as Business Ethics(Maxwell), 395

third party payer systemformularies and, 147

OTCs and, 134, 141public health care and, 133–135

“third world” nationsIP rights in, 257–259, 265patent protections in, 258

Thompson, Tommy, 341Thompson v. Western States Medical

Center, 190TNFα (tumour necrosis factor), 24Toprol XL, 143Trade Act (US), 457“tragedy of the commons,” 267, 268–272trials, clinical, 24

abuses during, 426candidate selection during, 330comparative pharmacokinetic studies

and, 38comparator products in, 46didanosine in, 304disclosure as part of, 319–320double-blind, 23, 24ethical review committees and, 45false data in, 315fixed-dose combination drugs and, 38foreign, 98–99funding sources for, 322–324guiding principles for, 318–324ICH and, 45informed consent as part of, 39international documents for, 39for new drugs, 38in New Zealand, 102The Nuremberg Code of 1947 and, 38patient’s rights and, 97–100, 105–106pediatric research and, 48, 51phases for, 46placebo-controlled, 63–65, 407, 416publication of, 46–47randomized (pediatric), 39risk management in, 285side effects during, 468sponsor obligations for, 45–46structured communication during,

320–322trials, clinical (placebo-controlled),

63–65, 407, 416Helsinki Declaration of Ethical

Principles for Medical ResearchInvolving Human Subjects and, 74

ICH and, 74IRBs and, 63






Index 491

mother-to-child HIV transmission, 222for pediatric research, 63–65, 74–75pediatric research and, 74–75priority principle in, 442rationing for, 442risks for, 65for steroids, 74–75WMA and, 64, 74

trials, clinical (randomized)clinical equipoise in, 62–63DMC in, 62IEC input on, 62for pediatric research, 62–65

Triomune, 349TRIPS agreement, 343, 346, 350, 351, 452.

See also Doha Declaration onTRIPS and Public Health

tropical indications. See diseases, tropicalTrovan, 143tubal embryo transfer. See TETtumour necrosis factor. See TNFα

Tuskegee syphilis study, 17African Americans as part of, 19, 101AP and, 101

UK (United Kingdom)cost guidelines in (new drugs), 238drug price controls in, 327drug recalls in, 25informed consent in, 197innovation output in, 333medical information in, 198–199new drug launches in, 25NHS Direct in, 202Stem Cell Bank in, 119stem cell research in, 119–120

UK Stem Cell Bank, 119UN International Covenant on Civil and

Political Rights (1966), 39UNAIDS (Joint United Nations

Programme on HIV/AIDS), 40“Ethical Considerations in HIV

Preventive Vaccine Research,” 40Universal Declaration of Human Rights

(1948), 40Upjohn, 171US (United States)

AMCP in, 238anthrax in, 267Clean Air Act, 114cloning restrictions in, 118

Contract With America in, 114cost per QALY in, 229Dickey Amendment in, 111drug recalls in, 25–26Energy Security Act, 114Foreign Assistance Act, 114The Global Fund to fight AIDS,

Tuberculosis and Malaria and,contributions to, 341

healthcare expenditures in (2002), 134,225

healthcare literature in, 232–234HIV/AIDS funding in, 341–342Human Cloning Prohibition Act, 113immunization program in, 386–387innovation output in, 333IP rights in, 267–268, 340IVF in, 116, 118MMA in, 239–240new drug launches in, 25Orphan Drug Act, 289Patent Office, 280patent protection in, 227, 350prescription drug sales, international

share, 227prescription drug sales within (2003),

153, 174, 226Public Health Service, 228regulation setting in, 116–118stem cell research in, government

policies for (by state), 118stem cell research in, government

policies for (general), 109, 122stem cell research in, laws for, 111–114Strategic Defense Initiative in, 114Superfund in, 114Trade Act in, 457Veteran’s Health Care Act, 288

US Patent Office, 280US Trade Representative reports. See

USTRUSTR (US Trade Representative)

reports, 339, 457Section 301 watch list in, 339

vaccine development centers. See VDCsVaccine Injury Compensation Program.

See VICPvaccine, polio, 372, 386

Rotary International and, 389–390Salk, Jonas, and, 372






492 Index

vaccines, 355–356. See also vaccine, polio;vaccines, HIV/AIDS; vaccines,influenza

childhood, 231–232, 355, 446Childhood Immunization Initiative,

256FDA and, 256future applications for, 354for HIV/AIDS, 274, 356–360influenza, 256–257, 352–354morbidity rates and, 356under National Childhood Vaccine

Injury Act, 449needles and, 387production process for, 256public funds for, 355shortages, 256, 449small pox, 355VICP and, 352

vaccines, HIV/AIDS, 356–360development of, 274VDCs and, 357

vaccines, influenza, 256–257, 352–353, 354delivery systems for, 353demands for, 353discarded, 352

Vagelos, Roy, 1, 4, 11, 399VDCs (vaccine development centers),

357venlafaxine, 77Veterans’ Health Care Act, 288Viagra, 213, 217–219

FDA approval for, 217as “lifestyle” drug, 217–218“off-label” uses for

VICP (Vaccine Injury CompensationProgram), 352

Vioxx, 13–14, 15, 134“Dodge Ball,” 14FDA and, 16mortality rates from, 16

Washington Legal Foundation. See WLFWashington Legal Foundation v.

Friedman, 439Washington Legal Foundation v. Henney,

439

The Washington Post, 375Weldon, Dave, 113Weldon, William, 251, 380, 393, 399Werhane, Patricia, 259, 380, 382, 383WHO (World Health Organization), 17,

236, 339, 387, 389, 452Asian bird influenza and, 291Collaborating Centers for Influenza,

353funding sponsor obligations for, 45GCP and, 37, 40, 43Mectizan Donation Program and, 372multiple perspectives system and, 279patents and, 244tropical diseases and, 31

WIPO (World Intellectual PropertyOrganization), 265

WLF (Washington Legal Foundation)Commercial Speech Doctrine and,

189–190FDA guidance documents and, 189First Amendment case law and,

190–191WMA (World Medical Association), 17,

102Helsinki Declaration of Ethical

Principles for Medical ResearchInvolving Human Subjects and, 17,37, 39, 40, 41, 42

on placebo-controlled clinical trials,64

womenHIV/AIDS and, 372

World Health Organization. See WHOWorld Intellectual Property

Organization. See WIPOWorld Medical Association. See WMAWorld Trade Organization. See WTOWTO (World Trade Organization), 258

Doha Declaration and, 258IP rules for, 346

Zantac, 141ZIFT (zygote intrafallopian transfer),

428Zoloft, 54zygote intrafallopian transfer. See ZIFT






Documents

Index [assets.cambridge.org]assets.cambridge.org/97805218/54962/index/9780521854962_index.pdf · Index AAP (American Academy of Pediatrics), 48, 57 Abbott Laboratories Fund, 277 abortion